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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
| Quality Systems | 18% | - Audits, corrective and preventive actions - Documentation, change control, and records management - Quality management system design and implementation |
| Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Filling, Packaging, and Labeling | 13% | - Packaging and labeling design and compliance - Filling operations, controls, and verification |
| Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
| Infrastructure and Facilities | 12% | - Equipment qualification, calibration, and cleaning validation - Facility design, maintenance, and utilities management |
| Manufacturing Systems | 16% | - Contamination control, cleaning, and hygiene - Process design, validation, and control - Sterile and non-sterile production requirements |
| Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Question 1
License withdrawal as an enforcement action results in:
Response:
A. A temporary pause in production for reevaluation.
B. The loss of the right to produce or sell the product.
C. Increased scrutiny in unrelated business areas.
D. The requirement to conduct more frequent advertising.
Question 2
When labeling reagents, solutions, and standards, which of the following information must be included?
Response:
A. Color and viscosity
B. Physical appearance and smell
C. Opened-on date, expiry date, and quantity
D. Price and supplier name
Question 3
Risk management principles in ICH Q9 should be applied:
Response:
A. Exclusively during clinical trials
B. Throughout the product lifecycle
C. Only at the beginning of product development
D. Only post-market
Question 4
Technology transfer is crucial when there is a __________ change.
Response:
A. sales team
B. marketing strategy
C. manufacturing site
D. packaging color
Question 5
Biological test methods in compendia are designed to:
Response:
A. Replace all chemical and physical tests.
B. Determine the biological activity or properties of substances.
C. Assess only the physical properties of a sample.
D. Be optional for all laboratory testing.
Solutions:
| Question 1 Answer: B | Question 2 Answer: C | Question 3 Answer: B | Question 4 Answer: C | Question 5 Answer: B |
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